Device recall
Z-0911-2016: MitraClip Clip Delivery System, product number MSK0101. The MitraClip System…
FDA device recall · Class I · Abbott Vascular
Key facts
| Recall number (Z-number) | Z-0911-2016 |
|---|---|
| Recall event | 73243 |
| Product | MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS) consists of three major… |
| Product code | NKM |
| Recalling firm | Abbott Vascular |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 12, 2016 |
| PMA numbers | P100009 |
| FEI number | 2024168 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database